The present invention relates generally to hypodermic needles having a means for indicating or covering a puncture site, and needle protecting devices such as retracting needles and needle guards for hypodermic needles including an apparatus for indicating or covering a puncture site and a means for selectively determining the depth of needle penetration into a vial or tissue.
The dramatic increase in the global proliferation of bloodborne pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and over twenty more known bloodborne pathogens transmitted via blood and bodily fluids, is having much broader socioeconomic ramifications than previously thought. Since the discovery of HIV and resulting Acquired Immunodeficiency Syndrome (AIDS) epidemic, approximately 65 million people have contracted the virus and an estimated 25 million people have died from AIDS-related illnesses. Meaning approximately 40 million individuals are living with HIV, with over 90% of those infected unaware of their infection and able to spread the disease. New data indicates the AIDS epidemic is spreading far more rapidly in the developing world than any global-level disease that preceded it. The epidemiological models previously used to predict the spread of other diseases are proving to be grossly inaccurate and useless. Although 1.3 million people living with AIDS in undeveloped countries have access to antiretroviral drugs, it is estimated that 80% do not have access to treatment. Without massive new intervention, experts predict an additional 70 million people will die from AIDS within the next two decades.
HIV prevalence is now approaching 40% of the population in some Sub-Saharan countries in Africa. New HIV infection rates in China, Indonesia, Latin America, South and Southeast Asia are exploding, with some infection rates increasing 70% in the first six months of 2001. The rate of new infections in the developed world has stabilized, but over 1.5 million are HIV-positive or living with AIDS. The United Nations is calling for unprecedented intervention to stem the growing number of people being infected with HIV.
In addition to the exploding population of those infected with HIV, a significant number of patients being treated with antiretroviral therapy are infected with a virus that has developed a resistance to any of the therapies currently available. In 2001, clinical studies in San Francisco determined that approximately 25% of HIV-positive patients being treated with the first and most widely available drug prophylaxis, reverse transcriptase inhibitors, had a HIV strain that developed drug-resistance within a short time. Researchers also monitored patients receiving the second generation antiviral drugs, non-nucleoside reverse transcriptase inhibitors, reporting no drug-resistant HIV strains in 1996, but were alarmed that 13% of those tested had developed a resistance to this new potent class of drugs. Both of these types of anti-viral drugs are expected to be widely used in the developing world because of cost. Even more alarming is the fact that 7% of HIV-positive patients receiving one of the third generation of antiretroviral drugs, protease inhibitors, also had an HIV strain that had developed a resistance to this treatment.
Additionally, the excitement over the new fourth generation CCR5 receptor antagonist class drugs that target the white blood cells of the immune system and not HIV itself has been tempered because the drugs may accelerate the shift of one variant of HIV to a second variant.
Another huge roadblock to the development of a vaccine or effective drug prophylaxis is the advent of dual HIV infection, where an individual is infected with two distinct HIV strains. The evidence of this phenomenon is the presence of recombinant viruses that include genetic material from two distinct parental HIV strains. The only way recombinant viruses are created is when simultaneous replication occurs between two distinct parental strains in the same patient. Dual infection can occur two ways: coinfection, when the host is infected with two distinct parental viruses at or around the same time, and; superinfection, where a sequential infection of two different viral strains occurs.
The presence of HIV or any of these bloodborne pathogens in patients poses a risk to healthcare workers when invasive, hypodermic procedures are performed. As the population of infected individuals' increases, more people will be treated by healthcare workers, further increasing the odds of disease transmission from patient to healthcare worker. Blood must be collected to determine and monitor the viral load in infected patients. The need for a passive blood collection system is enormous because of the increased demand for blood sampling.
The United States has mandated the use of safety engineered hypodermics in the workplace and many of the currently available safety products are not being well received by clinicians. The design of the great majority of these first generation safety devices requires a change in protocol, and an additional step or action to disable the contaminated hypodermic needle. The retracting syringe needles now available also require an additional step after the medication is administered with a syringe and the clinician is required to exert a significant force on the plunger rod to activate the retracting mechanism of the device. The retracting IV catheter, or the winged infusion needle, also requires the clinician to press a button to retract the needle into the needle hub or holder. One of the most glaring problems of the retracting needles are that they regurgitate the blood or bodily fluid contained in the needle when the needle retracts into the closed syringe, hub or handle. What is needed is a safety hypodermic needle that eliminates exposure time to the contaminated needle and does not harm the patient or caregiver.
The final result of any hypodermic or percutaneous procedure is that the puncture site is covered with a bandage, or wound dressing, after removal of the needle or stylet. The ability to simultaneously cover the puncture site during the procedure, or at the time of needle withdrawal, benefits the patient by reducing the time the wound is exposed to any potential air, skin or fluid-borne contaminants and potential infection, as well as the caregiver, who is now able to address the proper disposal of the contaminated needle without having to attempt to place a bandage or wound dressing, which may require the use of both hands. If a sharps container is not within reach, some caregivers routinely place the barrel of the used syringe in their mouth while placing the bandage over the puncture site.
Although an absorbent material is routinely used both before and after a hypodermic procedure, the existing prior art mostly teaches the use of the absorbent material to apply anesthetic or medication to the puncture site prior to needle insertion. In U.S. Pat. No. 4,799,926, Haber teaches a self-contained, sterile medication applying swab at the proximal end of a syringe plunger which is used prior to the puncture. In U.S. Pat. No. 4,243,035 Barrett also teaches a swab combined with a syringe, but with an integral swab at the distal end of the syringe for use prior to the puncture. Gringras, in U.S. Pat. No. 3,270,743, teaches a means for administering anesthetic from either the proximal end of the syringe, or the distal end of the needle cover. Golden, in U.S. Pat. No. 4,755,170, teaches a slidable, double portioned, cutaneous sealing apparatus, concentrically located about a needle, but does not teach a secure means to prevent the needle tip from being re-exposed after use nor includes a deployable bandage or wound dressing having an automatic peeling release liner. What is needed is a puncture site indicating or covering apparatus that is integral to the hypodermic apparatus, easy to use, includes a deployable bandage or wound dressing with a self-separating release liner and provides protection for both the patient and caregiver.
Some hypodermic needle diameters are so small that it is difficult to tell where the puncture has been made after the needle is withdrawn from the patient. Since a bandage is placed over the puncture site, an indicator marking the puncture site would be helpful to the attending clinician in properly placing the bandage or covering.
A simple needle shaft depth indicator is also disclosed in the present invention. The routine protocol has previously been to draw medication or diluent into a syringe with one needle, then to remove that fill needle from the syringe. A second, fresh, sterile needle is attached to the syringe and used to address the patient and inject the medicine. This protocol is common because each needle shaft is coated with a lubricating film designed to reduce patient discomfort and tissue drag when the needle is inserted into tissue. When the needle is passed through the stopper of the vial to fill the syringe, the lubricating film on the needle shaft is compromised. A small depth indicator near the distal end of the needle would allow the user to only insert a small portion of the needle shaft through the stopper into the vial, leaving the lubricating film intact on the rest of the needle shaft. Clinicians have been trained to visually observe the needle tip for burrs or other irregularities before using the needle on patients.
Hypodermic needles are used in a wide variety of invasive medical procedures with approximately 25 billion units being consumed on an annual basis. Basically, the great majority of hypodermic needles are disposable, intended for a single-use on an individual patient and are provided sterile in a variety of lengths and gauges. Hypodermic needles are normally discarded after a single use into a specially designed, puncture-proof biohazard container. Europe has broadly adopted disposable, single use regulations in light of the presence of Mad Cow disease.
Hypodermic needles are used in medicine, science, veterinary medicine, the biotechnology and pharmaceutical industries, and also in the chemical industry. Medical and veterinary uses range from injecting medication or diluent into a patient or I.V. port, collecting blood, bodily fluids or specimens from patients, placing guidewires, catheters and implanted ports, heart pacemaker leads, brain surgery and nuclear diagnostic medicine as well as a variety of other clinical procedures. The biotechnology and pharmaceutical applications mainly involve research where substances, liquids, gases or compounds are injected, mixed or withdrawn through a membrane or barrier into a specimen or controlled field. Chemical industry applications involve injecting or removing substances, liquids, gases or compounds to or from a specimen or controlled field. In each and every instance, whether medical or industrial, exposed needles pose a danger of injuring the user.
Despite all the obvious dangers associated with the use of exposed hypodermics, and the availability of manually activated safety hypodermic devices, unguarded, exposed hypodermic needles still are readily available and used throughout the industry. Many institutions have evaluated and tested the commercially available safety products and have rejected many of the technologies for a number of reasons.
The basic problem with many of the present day safety hypodermic devices is that they are meant to be manually activated, or in the language of the medical device industry, they are considered “active” devices. They may have safety shields, retractable needles, moveable sheaths or the like; but they generally require the user to complete another procedure to facilitate engagement of the safety mechanism. Although there are a number of retractable needle devices available, the aforementioned clinical issues are a cause for concern, as well as fluid regurgitation problems when the mechanism is activated.
What is needed is a low-cost safety hypodermic apparatus with a universal application that is low in cost, easy to use, and improves safety for both the patient and caregiver and should include a deployable bandage or wound dressing having a self-peeling release liner as an integral part of the safety hypodermic apparatus, reducing the probability of exposing the caregiver, or patient to contaminated hypodermic needles in the workplace.